CATEGORIES OF CLASS III DEVICES NOW COVERED BY ECM
The ECM designation is now extended to the following types of Class III Medical Devices:
Defibrillators
Non-Active Dental Devices
Software
CONTACT US
Take advantage of this extension of our Notification Scope and contact us to find out if your medical devices fall within our updated Notification Scope.
Contact our Sales Managers:
Diego Stevanella – diego.s@entecerma.it
Marzia Pellegrini – marzia.p@entecerma.it
Your Partner in Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable support. With our broad expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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To consult the updated list of reports of misuse of the name Ente Certificazione Macchine srl and/or the notified body number 1282, click here.
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IMPORTANT NOTICE: Immediate suspension of the use of the product “Hyperbaric chamber”
We would like to inform all our valued customers and business partners of an urgent measure that requires the utmost attention and timely cooperation from all users.